X PHNG GI U V TM DNG LNG TCVN 5493-91

Phng php xc nh hm lng clorua Shampoo for hair and bath Method for the determination of clorida content . Tiu chun ny p dng cho cc loi x phng gi u v tm dng lng ( smpun). Tiu chun ny khng p dng cho cc loi x phng c mu. Tiu chun ny ph hp vi ST SEV 5186-85. 1.Nguyn tc ca phng php Phng php da trn s chun mu th x phng bng bc nitrat vi ch th kali cromat v xc nh hm lng clorua. 2. Quy nh chung Khi tin hnh phn tch, phi s dng ho cht loi tinh khit phn tch v nc ct theo TCVN 2117-77. 3. Thit b , thuc th v dung dch 3.1 Bnh nn c rng, dung tch 250 cm3 3.2 Buret, dung tch 25 cm3 3.3 Bc nitrat, dung dch 0,1 mol / dm3 3.4 Kali cromat. Dung dch 10 % 3.5 Axit nitric, dung dch 1:4 3.6 Dung dch metyl , chun b nh sau: ho tan 0,1 g mety; trong 300 cm 3 ru etylic v 200 cm3 nc. 3.7 Ru etylic , 96% Ch thch : Khi tin hnh th nghim, cn s dng cc thuc th loi tinh khit phn tch v nc ct. 4. Tin hnh xc nh Cn vo bnh nn t 2 n 5 g mu th chnh xc n 0,005 g. Ho tan mu th trong 50 cm3 nc, thm 2 git metyl , nu dung ch c mu vng th trung ha bng axit nitric long n xut hin mu hng. Sau khi thm 2,5 cm3 dung dch kali cromat, chun b bng dung dch bc nitrat n chuyn mu ch th sang hng. 5. Tnh kt qu 5.1 Hm lng clorua trong mu th quy v natri clorua ( X ) tnh ra phn trm theo cng thc : V. 0,584 X =

m. trong : V- th tch dung dch bc nitrat nng 0,1 mol / cm3 0,084- h s tnh chuyn ra natri clorua. 5.2 Kt qu th nghim l gi tr trung bnh cng ca ba php xc nh song song c nng chnh lch khng vt qu 0,01%

X PHNG GI U V TM DNG LNG ( SAMPUN) TCVN 5494-91

Phng php xc nh hm lng sunfat Shampoo for hair and bath Method for the determination of sulphate content Tiu chun ny p dng cho cc loi x phng gi u v tm dng lng. Tiu chun ny khng p dng cho cc loi xf phng c mu. Tiu chun ny ph hp vi ST SEV 5190-85. 1. BN CHT CA PHNG PHP Phng php da trn vic chun in th mu th bng dung dch ch ( II ) nitrat khi c mt kali hexaxianoferat ngm 3 phn t nc v kali hexaxianoferat. 2. QUY NH CHUNG Khi tin hnh th, cn s dng cc thuc th loi tinh khit phn tch ( TKPT) v nc ct theo TCVN 2117-77 hoc nc c tinh khit tng ng. 3. DNG C V THIT B My o in th hoc my pH mt; in cc platin v caloment; My khuy in t hoc my khuy c hc; Buret, dung tch 100 cm3; Cc th nghim cao , dung tch 250 cm3 Cc th nghim, dung tch 100, 250 v 400 cm3, Bnh nh mc dung tch 100 v 1000 cm3; Giy lc mn. 4. THUC TH V DUNG DCH 4.1 Kali hexaxianoferat ngm 3 phn t nc K4 [ Fe (CN) 6 ] .3H2O, dung dch 0,005 mol/ dm3 chun b nh sau: cn 0,114 , g kali hexaxianoferat

ngm 3 phn t nc vi sai s khng qu 0,001 g, ho tan trong nc v chuyn nh lng vo bnh nh mc dung tch 100 cm 3, nh mc bng nc n vch, lc k. 4.2 Kali hexaxianoferat K3 [Fe (CN)6 ] , dung dch 0,1 mol / dm3 chun b nh sau: cn 3,290 g kali hexaxianoferat vi sai s khng qu 0,001 g , ho tan trong nc v chuyn nh lng vo bnh nh mc dung tch 100 cm 3, nh mc bng nc n vch, lc k. 4.3 Axit clohidric c v dung dch c nng 0,1 mol / dm3. 4.4 Kali sunfat, dung dch 1 %. Xc nh nng ( g / cm 3 ) ca dung dch nh sau: dng nc pha long 20 cm3 Kali sunfat trong cc dung tch 400 cm3 n 250 cm3 v thm 1 cm3 axit clohidric c. un si dung dch v dng pipet thm 10 cm3 dung dch bari clorua 5 %, dng a thu tinh khuy dung dch kt tahon ton( th vi bari clorua), sau khi xut hin ta, thm 5 cm3 dung dch bari clorua na. y cc v yn 1 h trn bp cch thu nhit 80 -900C ( khng si). Lc, ra kt ta bng nc n ht phn ng ca ion clua ( th vi bc nitrat). Cho giy lc v kt ta vo chn s nung trc nhit 700 0C n khi lng khng i, lc u t giy lc c kt ta nhit thp trong khng kh, sau nung kt ta nhit 7000C n khi lng khng i. Lng kali sunfat ( X) cha trong 1 cm3 dung dch tnh bng g/cm3 theo cng thc : m. 0,7465 X = 20 Trong : m-khi lng kt ta, g; 0,7465 - h s tnh chuyn khi lng bari sunfat ra kali sunfat 20 - th tch dung dch kali sunfat 1 % ly xc nh, cm 3 . Bari clorua, dung dch 5 %. Ch ( II ) nitrat dung dch 0,05 mol / dm3, chun b nh sau: cn 16,560 g ch ( II) nitrat vi sai s khng qu 0,001g sau khi sy 30 pht nhit 150 0 C ho tan trong nc. Chuyn nh lng vo bnh nh mc dung tch 1000 cm3, thm nc n vch v lc k. Xc nh nng phn t ca dung dch bng cch cho vo cc dung tch 250 cm3 ln lt: 10 cm3 dung dch kali sunfat, 15 cm3 nc, 50 cm3 ru etanola, 5 cm3 dung dch axit clohdric, 0,1 mo/ dm3 v 1 cm3 dung dch kali hexaxianoferat . Sau tin hnh chun in th. Lp my khuy v cc in cc vo dung dch nhn c. a my chun v trng thi lm vic v kim tra im khng. Va khuy va thm dung dch ch ( II) nitrat, mi ln 0,5 cm 3. o in th sau mt pht sau mi ln thm dung dch ch ( II) nitrat. Tin hnh chun n khi nhy th ri v ng cong chun , v trn trc honh th tch dung dch ch ( II ) nitrat v trn trc tung l gi tr in th tnh theo milivon. 4.5 4.6

Th tch dung dch ch ( II) nitrat( tnh bng cm 3) tiu tn cho chun mu th c xc nh theo hai tip tuyn ca ng cong. im tng ng nm ch gy ca ng cong chun . Nng phn t ca dung dch ch ( II ) nitrat ( X1) c tnh bng mol / dm3 theo cng thc: 100 .V1 . X X1 = m . 174,266 Trong : m- lng kali sunfat c trong 10 cm3 dung dch ly chun , g; V1- Th tch dung dch ch ( II) nitrat tiu tn cho chun mu th, cm 3. 174,266 - khi lng phn t ca kali sunfat. 4.7 Ru etanola 960 5. TIN HNH TH Cho 5 g mu th c cn vi sai s khng qu 0,001 g vo bnh nn hoc vo cc dung tch 250 cm3; thm 20 cm3 nc v khuy cn thn. Sau thm 50 cm3 etanola; 3 cm3 nc v khuy cn thn. Sau thm 50 cm3 etanola; 3 cm3 axit clohidric c, 0,1 cm3 dung dch kali hexaxianoferat ngm 3 phn t nc v 1cm3 dung dch kali hexaxianofferat. Tin hnh chun nh ch dn iu 4.6 6. TNH KT QU 6.1 Hm lng sunfat ( X2) ( tnh chuyn ra sunfat) c tnh bng phn trm theo cng thc: V . 142,06 X 2 = . 100 10 . m trong : V - th tch dung dch ch ( II ) nitrat 0,05 mol /dm3 tiu tn cho chun mu th , cm3; m- khi lng mu th,g. 6.2 Kt qu cui cng ca php th l trung bnh cng cc kt qu ca ba ln xc nh song song m sai lch gia chng khng vt qu 0,02 %. SA I TIU CHUN VIT NAM Sa i 1 ca TCVN 5816-1994 TCVN 5816-1994/ S 1: 1998

KEM NH RNG- YU CU K THUT V PHNG PHP TH

Amendement 1 of TCVN 5816 -1994; Tooth pastes Technical requirements and test methods 1. Phm vi p dng Sa i ny qui nh li mc v phng php th pH i vi kem nh rng c sn xut t cht to bt lauryl sunfat, canxi cacbonat, glyxerin v cc cht ph gia khc. 2. Ni dung sa i 1)Bng 1, iu 2.1 c sa li nh sau: Bng 1 Tn cc ch tiu 2.1 pH Mc v yu cu 5,5 10 5

2) iu 2.4 Xc nh pH ca dung dch - c sa li nh sau: Ho mt phn khi lng kem nh rng vi ba phn khi lng nc dng phn tch trong phng th nghim ( loi 2 ) theo TCVN 4851 -89 (ISO 3696). Dng my o ph vi in cc thu tinh v in cc calomen xc nh pH ca hn hp , tin hnh o trong vng 10 pht.

TIU CHUN VIT NAM

TCVN 6972-2001

NC GI DU
Shampoo 1 Phm vi p dng Tiu chun ny p dng cho nc gi u tng hp dng nguyn liu l nhng cht hot ng b mt d b phn hu sinh hc v mt s ph gia khc c b Y T cho php s dng trong m phm. 2 Tiu chun trch dn TCVN 1056 - 86 Thuc th. Phng php chun b cc thuc th dung dch v hn hp ph dng trong phn tch trc quang v phn tch c khuych tn. TCVN 3778 - 82 Thuc th. Phng php xc nh asen.

TCVN 4851 - 89 (ISO 3696-1987) Nc dng phn tch trong phng th nghim. Yu cu k thut v phng php th. TCVN 5454 :1999 (ISO 607-1980) Cht hot ng b mt v cht ty ra Phng php phn chia mu. TCVN 5456 - 91 Cht ty ra tng hp. Phng php xc nh ch s nng ion hidro ( pH). TCVN 5491 - 91 (ISO 8212-1986) Cht hot ng b mt v cht ty ra. Ly mu trong sn xut. Tiu chun gii hn vi khun, nm mc v phng php th ca b Y T quy nh cho m phm s 3113/1999/Q-BYT ngy 11/10/1999. Tiu chun kch ng da v phng php th ca b Y T quy nh cho m phm s 3113/1999/QBYT ngy 11/10/1999. 3 Yu cu k thut Yu cu k thut ca nc gi u phi ph hp vi cc quy nh trong bng 1 v bng 2. Bng 1 - Cc ch tiu ngoi quan Tn ch tiu 1. Trng thi Yu cu Lng snh, ng nht, khng tch lp, phn tng v kt ta khi bin i nhit hn 100C v ln hn 45 0C ng nht 2. Mu 3. Mi D chu, c trng cho tng sn phm

Bng 2 - Cc ch tiu cht lng

Tn ch tiu 1. Hm lng cht hot ng b mt , tnh bng phn trm khi lng, khng nh hn. 2. pH ca dung dch 1% 3. Hm lng asen tnh bng mg/kg , khng ln hn 4. Hm lng kim loi nng, tnh theo ch, bng mg/kg , khng ln hn 5. kch ng da 6. Vi khun v nm mc 6.1. Vi khun staphylococcus aureus, candida albicans v pseudomonas aeruginosa 6.2. Tng s nm mc sng li c, tnh bng s lng trong mt gam mu,

Mc cht lng 10 4-8 1 2 Khng ng k

Khng c php 100

khng c ln hn 6.3. Tng s vi khun hiu kh sng li c, tnh bng s lng trong mt gam mu, khng c ln hn 6.4. Tng s Enterobacteria v cc vi khun Gram m khc, tnh bng s lng trong mt gam mu, khng c ln hn 7. phn hu sinh hc, tnh bng phn trm khi lng, khng nh hn
4 Phng php th

1000 10 90

4.1 Quy nh chung

Ho cht dng phn tch l loi TKPT hoc TKHH Nc ct s dng theo TCVN 4851 - 89 (ISO 3696-1987); Cn phn tch, c chnh xc ti thiu 0,001g.

4.2 Ly mu v chun b mu
Ly mu v chun b mu theo TCVN 5454 : 1999 v TCVN 5491 : 1991 vi lng mu trung bnh ti thiu l 1000 g. Mu th nghim c cho vo bnh sch, kh, c nt kn, ngoi bnh c nhn ghi: tn cht ty ra; tn ni sn xut; ngy sn xut; ngy v ni ly mu;

4.3 nh gi ngoi quan sn phm

Ly khong 200 g mu vo cc thu tinh 500 ml. Dng mt quan st mu, cn tin hnh ni c nh sng, trnh nh sng trc tip, khng c mu sc khc gn v khng c mi l. Quan st cc c tnh sau: Trng thi: Mu sc: Mi: M t trng thi quan st c, c bit lu v tnh ng nht ca sn phm. M t mu sc quan st c. M t mi cm nhn c.

Th mu nhit nh hn 10 0C : Ly khong 200 g mu vo cc thu tinh dung tch 250 ml v t bnh n nhit 10 0C. Sau 24 gi mu t nhit ny, ly ra quan st. Th mu nhit ln hn 45 0C : Ly khong 200 g mu vo cc thu tinh dung tch 250 ml v t bnh n nhit 45 0C. Sau 24 gi mu t nhit ny, ly ra quan st. nh gi mu th theo cc yu cu qui nh iu 3 bng 1.

4.4 Xc nh hm lng cht hot ng b mt 4.4.1 Nguyn tc

Cc cht hot ng b mt c tch khi nc gi u bng etanol v c tnh sau khi tr i nhng thnh phn khc cng tan trong etanol nh clorua, glyxerin.

Chun mui clorua (tnh ra NaCl) bng bc nitrat vi ch th mu kali cromat. Da vo phn ng oxy ho kh ca glyxerin vi kali periodat trong mi trng axit, lng periodat d tc dng vi kali iodua gii phng iot. nh lng iot mi sinh bng chun vi natri t hiosunfat v tnh ra hm lng glyxerin.

4.4.2 Ho cht v thuc th

etanol 990; bc nitrat, dung dch 0,1 N; kali cromat, dung dch 10 %; axit nitric, dung dch 1 : 4; methyl , dung dch 0,1 % pha trong etanol; axit clohidric, d = 1,19 v dung dch 1 + 1; natri thiosunfat, dung dch 0,1 N; kali periodat, dung dch 0,1 N; kali iodua, dung dch 10 %; h tinh bt, dung dch 1 %.

4.4.3 Thit b v dng c:

t sy duy tr nhit 105 0C 2 0C; bp cch thu; bnh tam gic dung tch 100 ml; bnh tam gic c nt nhm, dung tch 250 ml; cc thu tinh, dung tch 250 ml; buret 25 ml.

4.4.4 Cch tin hnh 4.4.4.1 Xc nh tng hm lng cht tan trong etanol
Cn khong 5 g mu (chnh xc n 0,001 g) vo cc thu tinh dung tch 250 ml, thm vo 40 ml etanol. y cc bng mt knh ng h, un nng trn bp cch thu v khuy cho mu phn tn hon ton. Lc mu qua giy lc vo bnh tam gic dung tch 100 ml c sy kh v cn trc n khi lng khng i m0 (chnh xc n 0,001 g). Tip tc qu trnh ho tan trn hai ln na, mi ln vi 20 ml etanol. Thu gp tt c dung dch lc vo bnh tam gic trn v c nh bnh ny trn bp cch thu cho n khi ch cn li cn. Sy bnh tam gic ny nhit 105 0C n khi lng khng i. ngui bnh trong bnh ht m, sau 30 pht em cn l gi tr m1 (chnh xc n 0,001 g).

4.4.4.2 Xc nh hm lng mui clorua tan trong etanol

Ho tan phn cn sau khi xc nh cht tan trong etanol iu 4.4.4.1 trong 20 ml nc ct v thm hai git methyl , nu dung dch c mu vng th trung ho bng dung dch axit nitric 1 + 4 n mu hng. Cho vo 2,5 ml dung dch kali cromat 10 %. Chun bng dung dch bc nitrat 0,1 N n khi xut hin mu gch, th tch chun l V1. ng thi tin hnh th nghim mu trng vi tt c cc thuc th nhng khng c mu, th tch chun l V0.

4.4.4.3 Xc nh hm lng glyxerin tan trong etanol

Ho tan phn cn sau khi xc nh cht tan trong etanol iu 4.4.4.1 trong khong 25 ml nc v thm 5 ml dung dch HCl (1 + 1), chuyn dung dch vo bnh tam gic c nt nhm dung tch 250 ml, thm chnh xc 25 ml dung dch kali periodat, y nt, lc u mu, yn 15 pht. Ly mu ra, cho thm 20 ml dung dch axit clohidric (1 + 1) v 20 ml dung dch kali iodua. y nt, lc trn, yn trong bng ti 5 pht. Sau chun dung dch bng dung dch natri thiosunfat n mu vng nht, thm vo 1 ml dung dch h tinh bt v tip tc chun n khi mt mu xanh ca dung dch, th tch dung dch chun l V2ml. ng thi tin hnh th nghim mu trng vi tt c cc thuc th nhng khng c mu, th tch dung dch chun l V3 ml.

4.4.5 Tnh kt qu 4.4.5.1 Tng hm lng cht tan trong etanol

Tng hm lng cht tan trong etanol (X1), tnh bng phn trm khi lng, theo cng thc sau:

X1=
trong m0 - khi lng ca bnh, tnh bng gam;

(m1 - m0) x 100 m

m1 - khi lng ca cn v bnh, tnh bng gam; m - khi lng mu th, tnh bng gam.

4.4.5.2 Hm lng mui clorua tan trong etanol

Hm lng mui clorua tan trong etanol (X2), quy ra NaCl, bng phn trm khi lng (%), theo cng thc sau:

X2=
trong

(V1 - V0) x 0,0058 x 100 m

V1 - th tch bc nitrat 0,1 N dng chun mu th, tnh bng mililt; V0 - th tch bc nitrat 0,1 N dng chun mu trng, tnh bng mililt; m - khi lng mu th, tnh bng gam; 0,0058 - lng gam natri clorua tng ng 1 ml bc nitrat 0,1 N.

4.4.5.3 Hm lng glyxerin tan trong etanol

Hm lng glyxerin tan trong etanol (X3), tnh bng phn trm khi lng (%), theo cng thc sau:

X3=
trong

(V3 - V2) x 0,0023 x 100 m

V2 - th tch natri thiosunfat 0,1 N dng chun mu th, tnh bng mililt; V3 - th tch natri thiosunfat 0,1 N dng chun mu trng, tnh bng mililt; m - khi lng mu th, tnh bng gam;

0,0023 - lng gam glyxerin tng ng 1 ml natri thiosunfat 0,1 N.

4.4.5.4 Tng hm lng cht hot ng b mt tan trong etanol

Tng hm lng cht hot ng b mt tan trong etanol (X), tnh bng phn trm khi lng (%) theo cng thc sau X = X1 - (X2 + X3) trong X1 - tng hm lng cht tan trong etanol, tnh bng %; X2 - hm lng mui natri clorua tan trong etanol, tnh bng %; X3 - hm lng glyxerin, tnh bng %.

4.4.6 chnh xc ca phng php 4.4.6.1 lp li

Chnh lch tuyt i gia hai kt qu xc nh song song tin hnh trn cng mt mu th hoc c thc hin lin tip, do cng mt ngi phn tch, s dng cng loi thit b khng c vt qu 0,3 % cht hot ng b mt.

4.4.6.2 ti lp
Chnh lch tuyt i gia hai kt qu thu c trn cng mt mu th hai phng th nghim khng c vt qu 0,5 % cht hot ng b mt.

4.5 Xc nh pH
Thc hin theo TCVN 5456 - 91 Cht ty ra tng hp. Phng php xc nh ch s nng ion hidro ( pH).

4.6 Xc nh hm lng asen v kim loi nng 4.6.1 Chun b dung dch th
Cn khong 10 g mu (chnh xc n 0,01 g) vo bnh tam gic chu nhit dung tch 250 ml. Thm 10 ml axit sunfuric c v un nh trn bp in, sau tng dn nhit mu chy thnh dung dch snh mu nu en. ngui dung dch v thm dn tng git khong 5 ml axit nitric c v tip tc un si nh n khi dung dch tr thnh trong sut. ngui dung dch v trng thnh bnh bng khong 20 ml nc ct, thm 5 ml dung dch axit axetic 30 %, un si li dung dch mt ln na. Dung dch trong bnh trong sut, khng mu l t. ngui chuyn dung dch vo bnh nh mc dung tch 100 ml, nh mc n vch v lc k. Dung dch ny dng xc nh asen v kim loi nng.

4.6.2 Xc nh hm lng kim loi nng, tnh theo ch.

4.6.2.1 Nguyn tc Cc ion kim loi nng to vi dung dch natri sunfua kt ta mu en hay nu trong mi trng axit axetic pH= 3,5 - 4. So snh mu ca dung dch mu vi mu ca dung dch chun ch.

4.6.2.2 Ho cht v thuc th:

axit sunfuric, d = 1,84; axit clohidric, d = 1,19; axit nitric, d = 14,3; axit axetic, dung dch 30 % v (1 + 15); natri sunfua, dung dch 2 %;

amoniac, dung dch 25 % v (1 + 2); dung dch ch tiu chun A,1 mg/ml, chun b theo TCVN1056 - 86; dung dch ch tiu chun B, 0,010 mg/ml, ly 10 ml dung dch A cho vo bnh nh mc 1000 ml, nh mc ti vch bng nc v lc k; dung dch ch tiu chun C, 0,0001 mg/ml, ly 10 ml dung dch B cho vo bnh nh mc 1000 ml, nh mc ti vch bng nc v lc k; Dung dch B v C ch pha trc khi dng.

4.6.2.3 Dng c:
ng so mu Nessler 50 ml; bnh nh mc dung tch 100 ml, 1000 ml.

4.6.2.4 Cch tin hnh

Ht 10 ml dung dch mu iu 4.6.1 vo ng so mu Nessler. ng thi ly 20 ml dung dch tiu chun ch C vo ng so mu khc. Trung ho dung dch mu v dung dch tiu chun bng dung dch amoniac (1 + 2) theo ch th phenolphtalein n pht hng. Thm vo mi ng th 1 ml axit axetic v 0,5 ml dung dch natri sunfua. y nt v lc u. Sau 1 pht so snh mu ca ng dung dch th khng c m mu hn dung dch ca ng so snh. Khi so snh mu phi nhn t trn xung di, trn nn trng.

4.6.3 Xc nh hm lng asen 4.6.3.1 Nguyn tc Ly 10 ml dung dch iu (4.6.1) v xc nh asen theo TCVN 3778 - 82 Thuc th. Phng php xc nh asen. So snh mu giy ca mu vi mu giy ca dung dch tiu chun c 0,001 mg As. 4.7 Xc nh mc kch ng da Th nghim trn da th theo tiu chun kch ng da ca b Y T s 3113/1999/Q-BYT ngy11/10/1999. Xem ph lc A v B. 4.8 Xc nh gii hn vi khun v nm mc
Tiu chun gii hn vi khun, nm mc trong m phm ca b Y T s 3113/1999/Q-BYT ngy11/10/1999. Xem ph lc C. 5 Bo co kt qu

Bo co kt qu xc nh gm nhng mc sau y:
tt c cc thng tin cn thit nhn bit y v mu th; cc phng php s dng (theo tiu chun ny); cc kt qu thu c v cch biu th cc kt qu; cc chi tit ca mi thao tc khng qui nh trong tiu chun ny hoc cc tiu chun khc, hoc bt k thao tc tu no cng nh cc s c xy ra nh hng n kt qu. 6 Bao gi, ghi nhn, vn chuyn v bo qun sn phm

6.1 Bao gi
Nc gi u c ng trong cc hp bng nha, hoc chai thu tinh hoc bng cc vt liu khc theo tho thun gia nh sn xut v ngi tiu th.

Cc chai hoc hp nc gi u c xp trong bao b bng cc tng. m bo chc chn v an ton trong qu trnh vn chuyn v bo qun. S lng ng gi theo tho thun gia hai bn sn xut v tiu th.

6.2 Ghi nhn

Trn mi chai hoc hp nc gi u c nhn ghi: tn hng ho; tn v a ch c s sn xut; thnh phn v hm lng nguyn liu chnh; dung tch thc; hng dn s dng; ngy sn xut v hn s dng. Trn mi thng cc tng c nhn ghi: tn hng ho; tn v hm lng cc nguyn liu chnh; tn v a ch c s sn xut; s lng chai, hp; hng dn bo qun (k hiu che ma nng); hn s dng.

6.3 Vn chuyn
Vn chuyn bng phng tin thng dng. Trong qu trnh vn chuyn khng c chng xp qu cao trnh gy v, bp bao b sn phm v phi c che ma nng.

6.4 Bo qun
Bo qun nc gi u trong kho kh mt.

PH LC A
(Qui nh)

PHNG PHP TH KCH NG TRN DA

(p dng cho cc sn phm dng trong y t v m phm v ban hnh km theo Quyt nh s 3113/1999/Q-BYT ngy 11 thng 10 nm 1999 ca B trng B Y t)

A.1 Nguyn tc
Th kch ng trn da l mt phng php sinh hc da vo mc phn ng ca da th vi cht th so vi phn da k bn khng p cht th. Php th khng p dng cho cc cht axit hoc kim mnh (pH < 2 hoc pH > 11,5) v cc cht bit l c kch ng trn da.

A.2 Dng c th nghim

tng in hoc mt thit b thch hp lm sch lng th; ko, panh.

A.3 ng vt v iu kin th nghim

S dng th trng trng thnh, c hoc ci (khng s dng th c cha hoc ang cho con b), kho mnh, cn nng khng di 2 kg. Th c nht ring tng con v nui dng trong iu kin th nghim t nht 5 ngy trc khi th. Th nghim tin hnh trong nhit phng 25 0C 3 0C, m tng i 30 % - 70 %, nh sng bo m 12 gi ti, 12 gi sng hng ngy.

A.4 Chun b mu th
Mu th c chun b tu theo tnh cht v cch s dng trn ngi ca tng loi sn phm. Cht lng: dng trc tip hoc pha long vi dung mi thch hp. Cht rn: c th dng trc tip hoc tn thnh bt m vi dung mi thch hp m bo cht th c tip xc tt vi da. Vi cc cht rn khc khng th tn thnh bt, cn x l hoc chit xut trc khi s dng (phng php chit xut nguyn liu th sinh hc c thc hin theo hng dn ph lc A.1). Nu sn phm cui cng dng v trng, cht th s c tit trng vi cng iu kin nh trong qui trnh sn xut. Ch vi sn phm tit trng bng etylen dioxit v etylen dioxit v sn phm phn hu ca n c th gy kch ng. Cn c nh gi y nhng phn ng ca loi sn phm ny trc v sau khi tit trng. Dung mi dng pha long, lm m hoc chit xut l cc cht phn cc (nc, nc mui sinh l) hoc khng phn cc (du thc vt, du khong) khng gy kch ng.

A.5 Cch tin hnh A.5.1 Chun b sc vt

Trc ngy th nghim, lm sch lng th vng lng u v hai bn ct sng mt khong rng t cc mu th v i chng (khong 10 cm x 15 cm). Ch nhng th c da kho mnh, ng u v lnh ln mi c dng vo th nghim.

A.5.2 t mu th
Mi mu c th trn 3 th. Liu cht th trn mi th l 0,5 g hoc 0,5 ml. t mu th chun b trn ln ming gc khng gy kch ng 2,5 cm x 2,5 cm c dy thch hp ri p ln da. C nh

ming gc bng bng dnh khng gy kch ng t nht trong 4 gi. Sau b gc v bng dnh, cht th cn li c lm sch bng dung mi thch hp khng gy kch ng. Trong trng hp mu th c pha long hoc lm m bng dung mi, tin hnh song song t mu i chng l dung mi dng ch da bn cnh. S t mu th c th b tr theo hnh A.1. Hnh A.1 - S t mu th

A.6 Quan st v ghi im

Quan st v ghi im phn ng trn ch da t cht th so vi da k bn khng t cht th cc thi im 1 gi, 24 gi , 48 gi v 72 gi sau khi lm sch mu th. C th ko di hn thi gian quan st khi c tn thng su c th nh gi y hn v kh nng hi phc hoc khng hi phc ca vt thng nhng khng nn qu 14 ngy. nh gi phn ng trn da cc mc gy ban , ph n theo qui nh bng A.1. Bng A.1 - Mc phn ng trn da th

Phn ng
S to vy v ban Khng ban Ban rt nh (va nhn thy) Ban nhn thy r Ban va phi n nng Ban nghim trng ( ty) n to thnh vy d ngn nga s tin trin ca ban Gy ph n Tng s im kch ng ti a c th Nhng thay i khc trn da cn theo di v ghi chp y . Khng ph n Ph n rt nh (va nhn thy) Ph n nhn thy r (vin ph n phng ln r) Ph n va phI (da phng ln khong 1 mm) Ph n nghim trng (da phng ln trn 1 mm v c lan rng ra vng xung quanh)

im nh gi

0 1 2 3 4

0 1 2 3 4

A.7 nh gi kt qu
Trn mi th, im phn ng c tnh bng tng s im hai mc ban v ph n chia cho s ln quan st. im kch ng ca mu th c ly trung bnh im phn ng ca cc th th.

Trong trng hp c dng mu i chng, im phn ng ca mu th c tr i s im ca mu i chng. Ch s dng cc im nhng thi gian quan st 24 gi, 48 gi v 72 gi tnh kt qu. i chiu im kch ng vi cc mc qui nh trn bng A.2 xc nh kh nng gy kch ng trn da th ca mu th. Bng A.2 - Phn loi cc phn ng th trn da th Loi phn ng Kch ng khng ng k Kch ng nh Kch ng va phi Kch ng nghim trng im trung bnh T 0 n 0,5 ln hn 0,5 n 2 ln hn 2,0 n 5,0 ln hn 5,0 n 8,0

A.8 Bo co kt qu
Bo co kt qu cn ghi y cc thng tin v mu th, sc vt th (loi, s lng). Ghi chi tit cch chun b mu th v cch t mu trn da, Im ca cc ln quan st, nhng nhn xt thm nu c v nh gi kt qu. Ch thch
nh gi mc kch ng trn da khng nn ch da vo s Im kch ng m cn cn c vo nhng m t s thay i tnh trng da quan st c. Vic kt lun mu th t cht lng v ch tiu kch ng da hay khng phi ph thuc vo yu cu ring ca tng sn phm.

PH LC B
(Qui nh)

Phng php chit nguyn liu th sinh hc

(p dng cho cc sn phm dng trong y t v m phm v ban hnh km theo Quyt nh s 3113/1999/Q-BYT ngy 11 thng 10 nm 1999 ca B trng B Y t)

B.1 Gii thiu

tin hnh nh gi sinh hc cc nguyn vt liu, cn phi dng dng dch chit vi cc mi trng thch hp. Ph lc ny trnh by mt s phng php thng thng thu c dch chit th. Cc phn b sung, khng thay th s c ghi trong cc chuyn lun ring.

B.2 Dng c
ni hp c kh nng duy tr nhit 121 0C 2 0C; t sy hoc t m c kh nng duy tr nhit 70 0C 2 0C; 50 0C 2 0C; 37 0C 2 0C;

dng c ct (ko, dao, ca). Lm sch dng c ct bng kim loi vi mt dung mI hu c bay hI nh alcohol hoc axeton. Khng dng cc axit lm sch dng c kim loi; pipet c kch thc ph hp; cn chnh xc n 0,1 g; dng c o: thc o mm, compa; bnh chit; mi trng chit: s dng t nht mt trong hai loi mi trng sau: + dung mi phn cc: nc mui sinh l; + dung mi khng phn cc: du thc vt (v d du ht bng, du vng, t tiu chun EP hoc USP) hoc du khong trung tnh. Cc mi trng chit thch hp khc vi mi trng trn nh: ethanol/nc; ethanol/nc mui sinh l; polyethylen glycol 400; dimethyl sulfocid; aceton, methanol, chloroform, cht din hot pha long, du khong. B.3 Chun b mu B.3.1 Xc nh din tch b mt. + i vi cc mu c coi l ng u v mt hnh th, dng cch tnh din tch b mt theo cng thc hnh hc. Nu dy ca nguyn liu l di 0,5 mm, dung mt mu vi tng din tch b mt tng ng 120 cm2, chit trong 20 ml mi trng chit, m bo tt c b mt ca mu th c tip xc vi mi trng chit. Nu dy ca nguyn liu ln hn 0,5 mm, ly mu th vi tng din tch b mt tng ng 60 cm chit trong 20 ml mi trng chit, m bo tt c b mt ca mu th c tip xc vi mi trng chit.
2

+ i vi nguyn liu c hnh dng khng ng u, din tch b mt khng th xc nh c d dng, dng t 2 - 4 g mu, chit trong 20 ml mi trng chit. Cn nguyn liu c chnh xc 0,1 g. + Cc loi nguyn liu khc.

i vi cc nguyn liu m mi trng chit khng ngp ht din tch b mt mu th hoc khi mu c chia nh ng nht (nh bt bin), dng lng mu ln nht m th tch mi trng chit qui nh c th bao ph ht. Xc nh t l din tch b mt s dng v cn khi lng mu chnh xc n 0,1 g. + Cc nguyn liu khng th chia nh c. Vi cc nguyn liu khng th chia nh m khng lm mt i c tnh ca mu, ng nht hoc ton vn ca mu v th tch mi trng chit quy nh khng th bao ph ton b mu (v d cc dng c phc tp, vt kim loi, bn trong cc ti), dng mt lng ti thiu mi trng c th bao ph ht b mt mu th. Tu thuc vo loi nguyn liu, nh r hoc l khi lng (chnh xc n 0,1 g) hoc l din tch b mt (chnh xc n 1 cm2) c chit vi th tch dch chit qui nh chnh xc n 1 ml. B.3.2 Chun b 3.2.1 Kim tra mu th xem c b nhim bn b mt, sc ra v lm kh mu th, chit bng nc tinh khit hoc nc pha tim vi t l 70 ml/ 60 cm2 b mt. Sc ra trong t nht 30 giy ri gn b. Sc li nu cn, lm kh trc khi em chit. Ch : phn ln cc mu th c cung cp trong Iu kin v trng hoc trong bao gi sch. Vic thao tc bng tay v tip xc vi nhit kh thng khng m bo trn thc t, c th nh hng khng tt n kt qu ca mt s nghin cu. C th b qua giai on sc ra vi cc nguyn liu sch n c th cho php nh gi mt cch thc t hn nguyn liu v qu trnh sn xut. 3.2.2 Chia nh cc nguyn liu thnh cc mnh nh nu c th c. 3.2.3 Khi dy ca nguyn liu ln hn 1 mm v khng th chia nh c na, tnh b mt tip xc ca tt c cc mnh xc nh lng em dng. B. 4 Qui trnh chit B. 4.1 Cho nguyn liu th vo bnh chit c kch thc thch hp. ong th tch mi trng chit cn thit (chnh xc n 1 ml) ri ln nguyn liu th trong bnh. Trn u m bo cc nguyn liu tch ri, khng dnh vn li vi nhau. B. 4.2 Nu khng c ch dn g ring, chit mu th 370 C trong 72 gi. Khi tng nhit chit th c th gim thi gian chit theo cc t l iu chnh nh sau: 1210 C trong 1 0,2 gi 70 0C 50
0

trong 24 2 gi

C trong 72 2 gi

B.4.3 Mu i chng: tin hnh nh trn trong cng iu kin nhng vi dung mi v khng c mu th. B.4.4 Sau khi chit, khuy v gn dch chit sang bnh sch. Bo qun dch chit nhit phng, v dng trong vng 24 gi k t khi gn. Nu dch chit qu 24 gi, tin cy ca dch chit iu kin bo qun nn c kim tra. B.4.5 C th dng mt qui trnh chit thay th, s dng dung mi bay hi, sau bc hi dung mi v bi cn ln sc vt.

PH LC C
(Qui nh)

Tiu chun gii hn vi khun, nm mc trong m phm

(p dng cho cc sn phm dng trong yt v m phm v ban hnh km theo Quyt nh s 3113/ 1999/ Q-BYT ngy 11 thng 10 nm 1999 ca B trng B Y t) Tiu chun gii hn vi khun , nm mc trong m phm l vn bn qui nh v s lng ti a vi khun, nm mc khng c vt qu trong m phm v phng php th xc nh vi khun, nm mc trong m phm.

C.1 Gii hn vi khun v nm mc:

C.1.1 Trong m phm, khng c c cc vi khun sau: Staphylococcus aureus Candida albicans Pseudomonas aeruginosa

C.1.2 Tng s vi khun hiu kh sng li c khng c ln hn 1000/1 g hoc 1 ml sn phm C.1.3 Tng s nm mc sng li c khng c ln hn 100/ 1 g hoc 1 ml sn phm C.1.4 S lng Enterobacteria v cc vi khun Gram m khc khng c ln hn 10/ 1 g hoc 1 ml sn phm C.2 Phng php th C.2.1 Ly mu v chun b mu th nghim C.2.1.1 Ly mu Theo tiu chun ly mu kim nghim, mt mu em th phI lm t nht trn 03 n v ng gi nh nht. C.2.1.2 Pha ch mu th nghim. Tu theo tng sn phm, ly mt lng sn phm i din t cc n v ng gi (khong t 10-50 g hoc 10-50 ml sn phm) vo bnh nn, thm dung mi pha long thch hp pha long sn phm thnh cc nng em th nghim thch hp nh: 10-1, 10-2, 10-3 hoc 1/2; 1/5 ; 1/20 ; 1/40 v. v. . . sao cho khi m khun lc trn a Petri c ng knh 90-100 mm, s lng khun lc khng vt qu 300 trong mt a. C.2.2 Dng c v phng tin th nghim Th nghim c tin hnh trong cc Iu kin v trng, m bo khng c s ly nhim cc vi khun t ngoI vo mu th. Cc phng tin v dng c cn dng gm: - Hp Petri thu tinh c ng knh 90-100 mm Pipet chia vch c th tch 1; 5 v 10 ml. Bnh nn dung tch 100; 250 v 500 ml ng nghim cc loi 16-160 mm; 18-200 mm Ni cch thu n nh c nhit trong khong 35-45 0 C T m iu chnh nhit 32 0 C 1 0 C T sy

Ni hp tit trng My o pH

C.2.3 Ho cht Thch dng cho vi sinh vt Pepton dng cho vi sinh vt Natri clorid tinh khit (Na Cl) Glucose tinh khit Dinatri hydrophotsphat tinh khit Natri dihydrophotsphat Kali Dihydrophotsphat tinh khit Dikali hydrophotsphat tinh khit Acid lactic: dung dch 20 % hoc 30 % Acid citric : dung dch 20 % Natri hydroxit tinh khit (NaOH) Dung dch natri hydroxit 0,1 N N-dimethyl-phenylen diamin dihydroclorid Magnesi clorid Cetrimid (Cetyl trimethyl amoni bromid) Magnesi sulfat ngm nc Glycerin Tween 80 trung tnh Tm tinh th Xanh Brilliant

C.2.4 Mi trng C.2.4.1 Cc mi trng dng pha long, m cc vi khun, nm mc C.2.4.1.1 Nc Pepton Pepton Natri clorid Nc ct C.2.4.1.2 Nc mui sinh l Natri clorid Nc ct C.2.4.1.3 Mi trng thch Saboruaud Pepton Glucose 10 g 40 g 8, 5 g 1000 ml 1g 8,5 g 1000 ml

Thch Nc ct pH sau khi tit trng:

15-20 g 1000 ml 5,6 6 0,2

Cch pha: Ho tan cc cht trong nc, un nh la, khuy u cho tan hon ton. ng vo cc bnh dung tch 250 ml, mi bnh 150 ml. Hp tit trng trong ni hp 1100 C trong thi gian 15-20 pht. Mi trng c th bo qun 40 C v s dng trong vng 30 ngy. C.2.4.1.4 Mi trng thch thng Pepton Natri clorid Thch Nc ct pH sau khi hp tit trng 10 g 5g 15-20 g 1000 ml 7,4 -7,6

C.2.4.2. Cc mi trng dng phn lp vi khun, nm mc. C.2.4.2.1 . Mi trng thch Cetrimid Gelatin pancreatic 20,0 g

Magnegi clorid Glycerin

Cetrimid Thch Nc ct 0,3 g 13,6 g 1000 ml

1,4 g 10,0 ml

Cch pha: Ho tan tt c cc cht rn trong nc, thm glycerin. un nng, khuy u; un sI 1 pht cho tan hon ton. pH sau khi tit trng 7,2 0,2. C.2.4.2.2 Mi trng thch pht hin Fluorescin ca Pseudomonas Casein pancreatic Pepton Dikali hydrophotsphat khan Magnesi sulfat ngm nc 10,0 g 10,0 g 1,5 g 1,5 g

Thch
Glycerin Nc ct 10,0 g 1000 ml.

15,0 g

Cch pha: Ho tan tt c cc cht rn trong nc, thm glycerin. un nng, khuy u; un sI 1 pht cho tan hon ton. pH sau khi tit trng 7,2 0,2. C.2.4.2.3. Mi trng thch pht hin Pyocyanin ca Pseudomonas Gelatin pancreatic Magnesi clorid khan Kali sunfat khan Thch 20,0 g 1,4 g 10,0 g 15,0 g

Glycerin Nc ct

10,0 ml 1000 ml.

Cch pha: Ho tan tt c cc cht rn trong nc, thm glycerin. un nng, khuy u, un sI 1 pht cho tan hon ton. pH sau khi tit trng l 7,2 0,2. C.2.4.2.4 Mi trng RAT. Bt go Tween 80 Thch Nc ct pH sau khi tit trng Cao men bia Gelatin pancreatic Mui mt Lactose Natri clorid D-glucose monohydrat Thch trung tnh Tm tinh th Nc ct 3,9 g 7,0 g 1,5 g 10,0 g 5,0 g 10,0 g 15,0 g 30 mg 2 mg 1000 ml 15,0 g 10 ml 13,5 g 1000 ml 4,5 -5,5

C.2.4.2.5 MI trng thch mui mt c lactose v glucose, ch th tm tinh th, trung tnh.

iu chnh pH sao cho sau khi un l 7,4 0,2. un ti si nhng khng un trong ni hp. C.2.4.2.6 Canh thang lm giu Enterobacteriacease - Mossel Gelatin pancreatic: D-glucose monohydrat Mt b kh: Kali dihydrophosphat: Di natri hydrophosphat: Xanh Briliant: Nc ct: 10g 5,0g 20,0g 2,0g 8,0g 15,0mg 1000ml

iu chnh pH sao cho sau khi un l 7,2 0,2. un 1000 C trong 30 pht v lm lnh ngay. C.2.4.2.7 Mi trng thch Manitol-mui. Casein pancreatic Pepton Cao tht Natri clorid D-manitol 5,0 g 5,0 g 1,0 g 75,0 g 10,0 g

 phenol
Thch 15,0 g

25 mg

Cch pha: Trn, un nng, khuy u, sau un si 1 pht ho tan hon ton. pH sau khi tit trng: 7,4 0,2 C.2.4.2.7 Mi trng lng Casein u tng Casein pancreatic: Natri clorua: Dikali hydrophosphat Glucosa: Nc ct: 0,5 g 5,0 g 2,5 g 2,5 g 1000 ml

Bt u tng ( thu phn bi papain): 3,0 g

Cch pha: Ho tan cc cht rn vo nc, un nng nh cho tan hon ton. ngui dung dch nhit phng, phn chia vo cc bnh thch hp, em tit trng, pH sau khi tit trng 7,3 0,2 .

C.2.5 Tin hnh nuI cy, xc nh v phn lp 2.5.1 m tng s vi khun hiu kh, nm mc sng li c
2.5.1.1 Pha long sn phm: tin hnh theo iu 2.1.2 2.5.1.2 Cy truyn: Trc tin cy kim tra pipet trn mt a mi trng pht hin vi khun v mt a mi trng nm mc. Dng pipet v trng cy vo mi hp Petri 1 ml sn phm pha long, mi pha long cy vo 2 hp xc nh s lng vi khun hiu kh sng li c v 2 hp xc nh s lng nm mc sng li c. C.2.5.1.3 a un nng chy hon ton cc loi mi trng dng m vi khun, nm mc, ngui n 450C, rt vo cc hp Petri ( cy sn trong mi hp 1 ml ca mt pha long ca sn phm) mi hp 15 - 20 ml mi trng; trn u sn phm pha long vi mi trng bng cch xoay hp Petri qua phi v qua tri mi chiu 2-3 ln. a thch ng t nhin trn mt phng ngang. Thng dng mi trng thch thng m vi khun hiu kh Thng dng mi trng Sabouraud m nm mc C.2.5.1.4 m Sau khi cc a thch ng t nhin nhit phng, lt ngc a thch v em . Nhng a thch dng m vi khun c 32-350C, m khun lc mc trn a sau khi 48-72 gi. Nhng a thch dng m nm mc 256 20C, m khun lc mc trn a sau khi t 3-5 ngy. C.2.5.1.5 Tnh kt qu S lng vi khun hiu kh, nm mc sng li c c trong 1 g hoc 1 ml sn phm c tnh theo cng thc sau:

trong : M = S lng vi khun, nm mc sng li c c trong 1 g hoc 1 ml sn phm. C = Tng s khun lc m c cc a Petri cng mt pha long. n = S a trong mt pha long d = pha long N= S pha long (th d m hai pha long 101 v 102 : N =2; m nhng pha long 2,5 v 10 th N = 3 v.v...) 2.5.2 2.5.2.1 Phn lp vi khun Tm Staphylococcus aureus

Cho ch phm vo 100 ml mi trng lng casein u tng, m 350C trong khong 24-48 gi. Quan st mI trng, nu thy vi khun mc, dng que cy ly mt quai cy, cy ln mt a thch Mannitolmui. y a, lt ngc hp Petri, em m 350C trong 24 gi. Sau khi m, kim tra nu thy: Trn a thch Mannitol- mui c thy nhng khun lc mu vng cng vi mt vng mu vng xung quanh, dng que cy ly khun lc In hnh, em nhum Gram, soi knh thy t cu khun hnh chm nho, bt mu gram dng, ng knh khong 0,8 - 1mm; tip tc lm cc phn ng sinh vt ho hc ca Staphylococcus aureus. Chuyn mt lc khun nghi ng c trng vo ng nghim nh, sch v trng, thm vo ng 0,5 ml huyt tng th. em m cch thu 370C; sau 3 gi m, kim tra cc ng th, tip tc m thm 24 gi. Nu thy c hin tng ng huyt tng bt k mc no - sn phm c Staphylococcus aureus. 2.5.2.2 Tm Pseudomonas aeruginosa Cho ch phm vo 100 ml mI trng lng casein u tng, m 350C trong 24-48 gi. Quan st mi trng, nu thy vi khn mc, dng dng que cy ly mt quai cy, cy ln mt a thch Cetrimid. y a, lt ngc hp Petri v em m 350C trong 24 gi. sau khi m, kim tra nu thy: Trn mi trng thch Cetrimid c khun lc mu lc nht, c nh hunh quang mu lc, th ly khun lc , nhum gram v soi knh. Nu thy trc khun Gram m v phn ng oxydaza dng tnh th tip tc cy truyn trn mt mi trng thch Pseudomonas pht hin fluorescin v mI trng thch Pseudomonas pht hin pyocyamin trong hp Petri. y v lt ngc hp mi trng cy truyn, em m 35 20C trong t nht 3 ngy, em kim tra cc a thch di nh n t ngoi, ny thy: Trn a thch Pseudomonas pht hin fluorescin c khun lc khng mu n mu vng, c hunh quang hi vng. Trn a thch Pseudomonas pht hin pyocyamin c khun lc mu vng nht, c hunh quang mu xanh nc bin. Tip tc nhum gram, soi knh v lm phn ng oxydaza thy trc khun gram m, phn ng oxydaza dng tnh, c th kt lun c Pseudomonas aeruginosa.Nu cha chc chn c th tip tc kim tra bng cc php th sinh ho khc. Th phn ng oxydaza: Chuyn khun lc vo mu giy tm trc N-dimethyl phenylen diamin dihydroclorid, nu thy hin mu hng, chuyn sang mu tm: phn ng oxydaza dng tnh. 2.5.2.3 Enterobacteriaceae v cc vi khun gam m khc. Lm ng nht ch phm em kim tra bng cch x l mt lng thch hp nh m t trn v m 35-37 0 C trong mt thi gian thch hp phc hi li vi khun, nhng khng phI lm tng vi khun(thng t 2-5 h). Lc bnh cha v chuyn mt lng ch phm ng nht tng ng vi khong 1 g hoc 1 ml ch phm vo 100 ml mi trng canh thang lm giu Enterobacteriaceae - Mosel v m 35-37 0C trong 18-24 h.Cy ln a thch mui mt c lactose, glucose, ch th tm tinh th v

 trung tnh, m 35- 370C trong 18- 48 h. Ch phm khng c Enterobacteriaceae nu khng thy mc nhng khun lac vi khun gram m trn thch a. nh gi s lng: m mt lng thch hp mi trng canh thang lm giu Enterobacteriaceae Mosel vi nhnglng ch phm em kim tra c lm giu ng nht cha 1,0 g; 0,1 g; v 0 ,01 g hoc 1,0 ml; 0,1 ml v 0,01 m. Ch phm c th c pha long khi cn. n 35 0-370 C trong 24 n 48 gi. S mc ca cc khun lc pht trin tt thng hoc a , vi khun gram m chng t kt qu dng tnh. Ghi lng nh nht ca ch phm m cho kt qu dng tnh v lng ln nht ca ch phm m cho kt qu m tnh. Xc nh theo bng sau s lng Bacteria Bng B1- Tnh lng Bacteria trong ch phm Kt qu i vi mi lng sn phm 1,0 g hoc 1,0 ml + + + 0,1 g hoc 0,1 ml + + 0,01 g hoc 0,01 ml + S bacteria c trong 1 g sn phm

Ln hn 10 2 t hn 10
2

nhng ln hn 10

t hn 10 nhng ln hn 1 t hn 1

2.5.2.4 Tm Candida albicans Tin hnh trn mI trng thch Sabouraud Vo cui giai on m, kim tra bng knh hin vi xem c nm mc hay khng. Kim tra s c khun lc nghi ng Candida albicans. Ly khun lc In hnh em nhum gram, soi knh: Candida albicans c hnh trn, bu dc ng knh 6-9 mm, bt mu gram dng. Th nghim mm gi u: Ly mt git huyn dch nm nuI cy sau 24 h vo ng nghim nh c cha 1 ml huyt thanh th, m 370 C trong 3 h, sau ly ra soi gia bn v l knh. Nu l nm Candida albicans th gn nh ton b s t bo s ny mm ging nh hnh - gi u . Tm t bo vch dy: Cho mI trng RAT ln bn knh v khun, nh vo mt git huyn dch nm , y l knh, c kt qu sau 24 - 48 gi m 30 0C ___________________________________

Ph lc
B Y T S: 3113/1999/QQ-BYT ------------Cng ho X hi Ch ngha Vit nam c lp - T do - Hnh phc -------------------------------H ni ngy 11 thng 10 nm 1999

Quyt nh Ca B Trng B Y T
V vic ban hnh Tiu chun gii hn vi khun, nm mc trong m phm v Phng php th kch ng trn da B Trng B Y T -Cn c Lut bo v sc kho nhn dn ban hnh ngy 11 / 7 /1989 v Iu l thuc phng bnh, cha bnh ban hnh km theo Ngh nh s 23/ HBT ngy 24/02/1991 ca Hi ng B trng (nay l Chnh ph); -Cn c Php lnh cht lng hng ho ngy 27/12/1990 ca Ch tch Hi ng Nh nc v Ngh nh s 327/HBT ngy 19/10/1991 ca Hi ng B trng(nay l Chnh ph) qui nh thi hnh Php lnh cht lng hng ho; -Cn c Ngh nh s 68/CP ngy 11/10/1993 ca Chnh ph quy nh chc nng nhim v , quyn hn v t chc b my B Y t; -Cn c Ngh nh s 86/CP ngy 08/12/1995 ca Chnh ph quy nh phn cng trch nhim qun l Nh nc v cht lng hng ho; -Xt ngh ca Cc trng Cc Qun l Dc Vit nam; Quyt nh iu 1: Nay ban hnh km theo Quyt nh ny: 1-Tiu chun gii hn vi khun, nm mc trong m phm 2- Phng php th kch ng trn da (p dng cho cc sn phm dng trong y t v m phm) iu 2: Quyt nh ny c hiu lc sau 15 ngy k t ngy k ban hnh. Cc quy nh trc y tri vi quy nh trong Quyt nh ny u b bi b. Iu 3: Cc ng, B Chnh vn phng, Chnh thanh tra, V trng V u tr, V trng V khoa hc o to- B Y t, Cc trng Cc Qun l Dc Vit nam, Vin trng Vin Kim nghim, Th trng cc n v trc thuc B, Gim c S Y t cc tnh, thnh ph trc thuc Trung ng, Y t ngnh chu trch nhim thi hnh quyt nh ny.